Intravenous catheter assembly

ABSTRACT

A self-contained sterile catheter apparatus for use with an intravenous cannula element. The cannula element has first and second ends and a bore formed therebetween, and is configured for transcutaneous positioning such that the first end is adapted to protrude from a limb of a subject and the second end is brought into communication with an interior of a body organ of a subject. The self-contained sterile catheter apparatus includes first and second ends and a flexible catheter tube therebetween, the catheter tube having a predetermined length and a diameter adapted for slidable insertion through the bore of the intravenous cannula element into the subject, and an integral sterile environment containment element thereby to allow insertion of the catheter tube through the cannula element into the subject in a generally non-sterile environment.

FIELD OF THE INVENTION

The present invention relates, generally to intravenous catheters and,more specifically, to flexible intravenous catheters.

BACKGROUND OF THE INVENTION

It is known in the art to provide peripheral intravenous therapy using acatheter having a short cannula or catheter tube to provide access intosubcutaneous veins thereby to introduce medication, drugs, chemotherapy,nutrition and various other fluids into a vein of a subject. The presentprocedure includes inserting a hypodermic needle together with acatheter having a cannula into a suitable vein site, withdrawing theneedle and leaving the catheter cannula in the vein. Such a catheter isprovided with a suitable closure and various adapter mechanisms toenable the introduction of fluid medicaments from a hypodermic syringeor from an intravenous drip.

Studies over the past thirty years have shown that, up to seventypercent of subjects receiving peripheral intravenous therapy, develop aninflammatory reaction to the vein known as phlebitis. These studiesinclude:

-   Maki D G, Goldman D A, Rhame F S: “Infection control in intravenous    therapy” Ann Intern Med 1973; 79:876-87;-   Turnidge J: “Hazards of peripheral intravenous lines” Med J Aust    1984; 141:37-40;-   Lewis G B, Hecker J F: “Infusion thrombophlebitis” Br J Anaesth    1985; 57:22-33;-   Hessov I: “Prevention of infusion thrombophlebitis” Acta    Anaesthesiol Scand Supple. 1985; 29:33-37;-   Turen S J: “Infusion phlebitis: a review of the literature”    Parenterals 1987; 14:37-40; and-   Maki D G, Ringer M: “Risk factors for infusion-related phlebitis    with small peripheral venous catheters”.

Phlebitis necessitates the removal of the cannula, reinsertion of acannula into an alternative site and, often, local treatment andanalgesic drugs. The extent of this problem is best understood by thefact that about fifteen percent of the general population is admittedannually into hospitals. Approximately seventy percent of admittedhospital subjects receive intravenous treatment. The majority of suchsubjects require treatment extending over three days or more. Theincidence of phlebitis has been found to exceed fifty percent of allsuch subjects by the fourth day after cathetization and, in the case ofsubjects receiving intravenous antibiotics, the risk is doubled.

With these subjects, there are many risk factors influencing theincidence of phlebitis, including an increased risk in female subjects,the specific anatomic site of insertion and a previous history ofphlebitis. In addition, structural parameters, such as the materialsused in the manufacture of small catheters, add to the risk of phlebitisas described in Maki D G et al, above. Specifically the risk ofinfection increases with time and it is generally recommended that thecatheter site be changed every three days.

Actual infection of the catheter end is not a common cause of phlebitis.The most common cause is chemical irritation, specifically in subjectshaving chemotherapy or peripheral intravenous nutrition. Such subjectsgenerally have multiple treatments or long-term hyperosmolar fluidintroduction. Subjects suffer pain as well as long-term damage ordestruction of veins, making determining new insertion sites moreproblematic and sometimes frustrating and time-consuming for the medicalprofessional.

There are several alternatives to peripheral intravenous therapy using ashort catheter, namely:

-   -   Central venous catheter with or without the use of subcutaneous        ports known as a Porta-cath,    -   Peripherally inserted central lines (PICC lines), and    -   Peripheral ports.

These alternatives are referred to in:

-   Schuman E, Ragsdale J: “Peripheral ports are a new option for    central venous access” J Am Coll Surg 1995; 180:456-60;-   Lyon R D, Griggs K A, Johnson A M, Olsen J R: “Long-term follow-up    of upper extremity implanted venous access devices in oncology    subjects” J Vasc Interv Radiol 1999; 10:463-71;-   Jills J R, Cardella J F, Cardella K, Waybill P N: “Experience with    100 consecutive central venous access arm ports placed by    interventional radiologists” J Vasc Interv Radiol 1997; 8:983-9;-   Minassian V A, Sood A K, Lowe P, Sorosky J I, Al-Jurf A S, Buller R    E: “Longterm central venous access in gynecologic cancer subjects” J    Am Coll Surg 2000; 191:403-9; and in-   Reynolds J V, Walsh K, Ruigrok J, Hyland J M: “Randomised comparison    of silicone versus Teflon cannulas for peripheral intravenous    nutrition” Ann R Coll Surg Engl 1995; 77:447-9.

It has recently been shown by Jills J R, et al, hereinabove, and inPullyblank A M, Carey P D, Pearce S Z, Tanner A G, Guillou P J, Monson JR. Ann R. Coll Surg Engl 1994; 76:33-8, that peripheral access systemports have a longer life and a lower infection risk compared to acentrally placed catheter. Nonetheless, peripheral access system portsare found to be invasive, incur various complicating factors and have tobe removed in the event of a fever developing.

PICC lines have been shown to be able to be left in place for longerperiods of time but are relatively expensive. Furthermore, PICC linesare not widely used because the technique for insertion differs fromthat used most frequently by medical professionals. Insertion requiresthe placement of a primary catheter, and insertion of a line through thecatheter followed by removal of the primary catheter. Longer cathetersappear to reduce the phlebitis risk as described in

-   Linder L E, Wojciechowski J, Zachrisson B F, Curelaru I, Gustavsson    B, Hultman E, Bylock A. “Half-way” venous catheters. IV.    Clinical-experience and thrombogenicity Acta Anaesthesiol Scand    Suppl 1985; 81:40-47, and in-   Pearson M L. Guideline for prevention of intravascular device    related infects. The Hospital Infection control practices advisory    committee. Center for Disease Control and Prevention.

It has been repeatedly shown that use of a PCC line drastically reducesthe incidence of phlebitis. However, much practice is needed to properlycarry out an insertion. Moreover, in up to thirty two percent of cases,the PCC line procedure had to be repeated as a result of the appearanceof phlebitis, or the clogging or tearing of the catheter.

Referring now to U.S. Pat. No. 5,704,919 to Menachem Kraus et alentitled “Intravenous Cannula Assembly” there is disclosed anintravenous assembly having a distal end insertable into a subject.There is provided a guide needle, which is moved into a requiredposition with respect to a cannula such that the sharp extremity of theneedle projects beyond the distal end of the cannula. A subcutaneousvein is pierced with this mechanism and the guide needle retracted viathe proximal end of the cannula, from which it is removed into aprotective enclosure, leaving the cannula positioned within the vein.

The cannula described in the foregoing patent is relatively short, thedistal end being positioned within the vein relatively close to theinsertion site. In the event that the patient requires extendedintravenous therapy, it is necessary to re-insert a new cannula into analternative subcutaneous vein site every few days to avoid phlebitis orthrombosis. This causes the patient additional trauma, requiresadditional time spent by the medical professional and necessitateshaving a sterile field of operation.

It is apparent that there is a need in the art to provide a solution toor an alleviation of the problems of phlebitis and thrombosis, caused bypresently available techniques for intravenous therapy. The choice sitegenerally selected by medical professionals is the cephalic vein in theforearm. It is large and accessible and any infusion set can be securedout of the way, making it less likely to be pulled out accidentally.Should relocation prove necessary, there exists only one other suchchoice site, leaving alternatives, which are less ideal. This is mostespecially the case where a number of vein entries are necessitated.There is a need in the art, therefore, to reduce or avoid the necessityfor frequently relocating intravenous sites.

SUMMARY OF THE INVENTION

The present invention aims to provide an improved intravenous cathetersystem, such that problems associated with current practice are avoidedor minimized. Specifically, in accordance with current practice forpatients having extended intravenous therapy, on average, it is requiredto reposition an intravenous catheter, every three days. Re-positioninga subcutaneous intravenous catheter is necessitated as a result ofoccurrence of phlebitis or thrombosis in the vein in the vicinity of thecatheter tip. Other circumstances, such as a patient developing a fever,may also require the repositioning of a catheter.

The present invention relates to an improved intravenous catheter systemincluding a multi-use entry-port element having first and second endshaving a bore formed there-between. The entry-port element is configuredfor transcutaneous positioning such that the second end is brought intoliquid flow communication with a vein of a subject. The system furtherincludes a catheter having first and second ends and a flexiblecatheter-tube there-between, the catheter tube having a predeterminedlength and a diameter adapted for slidable insertion through theentry-port element into the vein of the subject.

The present invention also relates to a self-contained sterile catheterapparatus, for use with an intravenous cannula element having first andsecond ends and having a bore formed therebetween, the cannula elementconfigured for transcutaneous positioning such that the first end isadapted to protrude from a limb of a subject and the second end isbrought into communication with an interior of a body organ of asubject, the self-contained sterile catheter apparatus includes

-   -   first and second ends and a flexible catheter tube therebetween,        the catheter tube having a predetermined length and a diameter        adapted for slidable insertion through the bore of the        intravenous cannula element into the body organ of the subject,        and    -   an integral sterile environment containment element thereby to        allow insertion of the catheter tube through the cannula element        into the body organ of a subject in a generally non-sterile        environment.

According to a preferred embodiment of the present invention, there isprovided an improved intravenous catheter system in which the multi-useentry-port element includes

-   -   a hub having a slide adapter-connector fixably disposed at the        first end of the entry-port element, thereby to provide sealed        slidable access of the catheter-tube into the entry-port element        and thereafter into the vein of the subject;    -   a cannula having an aperture formed at a second end thereof, the        cannula fixably attached to the hub and disposed at the second        end of the entry-port element, the cannula adapted for insertion        into the vein of the subject; and    -   a removable needle, having first and second ends, a needle-hub        attached at the first end, a sharp extremity at the second end        and a length sufficient to extend through the entry-port        element, the needle slidably housed in the entry-port, the sharp        extremity projecting beyond the aperture at the second end of        the cannula thereby to pierce through the skin and vein wall        into the vein of the subject, and thereby to provide entry into        the vein for the cannula.

According to another preferred embodiment of the present invention,there is provided an improved intravenous catheter system in which thecatheter includes

-   -   a connector element disposed at the first end of the catheter        and having a removable cap, the connector element configured to        facilitate, in the absence of the cap, connection of an        intravenous therapeutic device to the first end of the catheter;        and    -   a slidable-connector element disposed at the second end of the        catheter and having a removable cap, the slidable-connector        element, configured to facilitate connection of the second end        of the catheter to the first end of the entry-port element and        thereby to facilitate sliding the catheter tube therethrough        into the entry-port element and into the vein of the subject.

According to another preferred embodiment of the present invention,there is provided an improved intravenous catheter system also includingan integral sterile environment containment element thereby to allowinsertion of said catheter tube through said cannula element into thevein of a subject in a generally non-sterile environment. Furthermore,according to variations of the preferred embodiment of the presentinvention the integral sterile environment containment element includesa longitudinal disposable sheath configured to contain the catheter tubelongitudinally therewithin or a cylindrical casing configured to containthe catheter tube as a withdrawable coil therewithin.

According to another variation of the preferred embodiment of thepresent invention the entry-port element has mounting lugs fixablydisposed thereto, for securing the entry-port element to the subject.

According to a further variation of the preferred embodiment of thepresent invention the second end of the cannula is formed with a taper,thereby to provide a compression lip seal between the cannula apertureand the catheter tube.

According to additional variations of embodiments of the presentinvention the connector element and the slide adapter-connectorconfigured at the first and second ends of the catheter, respectively,includes a Luer Lock.

According to another embodiment of the present invention, there isprovided an improved intravenous catheter system in which a removablestiffener element is slidably disposed within the flexible cathetertube. This stiffener element increases the stiffness of the cathetertube, and aids insertion thereof through the entry-port element into thevein of the subject.

According to further embodiments of the present invention, there isprovided an improved intravenous catheter system in which the entry-portelement includes a selectably operable locking device for locking thecatheter tube in a selected position with respect to a selected drugdelivery location within the vein of the subject. Also, there isincluded a valve for regulating a flow of liquid through the cathetertube.

The present invention also relates to a self-contained sterile catheterapparatus, for use with an intravenous cannula element having first andsecond ends and having a bore formed therebetween. The cannula elementis configured for transcutaneous positioning such that the first end isadapted to protrude from a limb of a subject and the second end isbrought into communication with an interior of a body organ of asubject, the self-contained sterile catheter apparatus includes

-   -   first and second ends and a flexible catheter tube therebetween,        the catheter tube having a predetermined length and a diameter        adapted for slidable insertion through the bore of the        intravenous cannula element into the body organ of the subject,        and    -   an integral sterile environment containment element thereby to        allow insertion of the catheter tube through the cannula element        into the body organ of a subject in a generally non-sterile        environment.

In accordance with an embodiment of the present invention, for use withan intravenous cannula element the catheter includes

-   -   a connector element disposed at said first end of said catheter        and having a removable cap, said connector element configured to        facilitate, in the absence of said cap, connection of an        intravenous therapeutic device to said first end of said        catheter; and    -   a slidable-connector element disposed at said second end of said        catheter and having a removable cap, said slidable-connector        element, configured to facilitate connection of said second end        of said catheter to said first end of said entry-port element,        thereby to facilitate sliding said catheter tube therethrough        into said entry-port element and thereafter into the vein of the        subject.

In accordance with another embodiment of the present invention, for usewith an intravenous cannula element the integral sterile environmentcontainment element is selected from the group, which consists of:

-   -   a longitudinal collapsible sheath configured to contain the        catheter tube longitudinally therewithin; and    -   a cylindrical casing configured to contain the catheter tube as        a withdrawable coil therewithin.

In accordance with a variation of the aforementioned embodiment of thepresent invention the cylindrical casing includes a clutch devicethereby to control forceful insertion of the catheter tube through theentry port into a vein, so as to avoid damaging the vein wall.

In accordance with another embodiment of the present invention, there isa flexible catheter tube for use with an intravenous cannula element andalso including a removable stiffener element slidably disposed withinthe flexible catheter tube. This has the effect of increasing thestiffness of the catheter tube, and thereby to aid insertion thereofthrough the entry-port element into the vein of the subject.

Furthermore, there is provided a method for introducing an improvedintravenous catheter system into a subcutaneous vein of a subject. Themethod includes

-   -   introducing a multi-use entry-port, having a removable        piercing-needle slidably housed therein, into an outer wall of a        subcutaneous vein of a subject,    -   withdrawing the removable piercing-needle from the entry-port,    -   advancing the multi-use entry-port into the vein,    -   connecting a catheter device, having a flexible catheter tube,        to the entry-port, and    -   slidably inserting the flexible catheter-tube through the        entry-port into the subcutaneous vein of the subject.

According to a further embodiment of the present invention, the methodincludes the step of securing the entry-port element to the skin of thesubject.

According to another embodiment of the present invention, withdrawingthe removable piercing-needle from the entry-port includes partiallywithdrawing the removable piercing-needle from the entry-port after thevein wall has been pierced, to guard the sharp extremity of the piercingneedle and to avoid transfixing the vein.

According to an additional embodiment of the present invention, whenusing a catheter tube having a removable stiffener element slidablydisposed therein, the method includes slidably removing the stiffenerelement from the catheter.

An additional embodiment of the present invention provides for therepeated use of a catheter inserted through a multiple entry-portwithout having to repeatedly relocate the catheter vein-site every fewdays. Catheters of different lengths are used to avoid repetitivelocation of the catheter tip at the same location within thesubcutaneous vein. Alternatively, there is provision for adjusting theposition of a catheter end and locking the catheter tube in each newposition. The problem of phlebitis is substantially reduced. Patients donot have the repeated trauma of having the catheter re-inserted intoother vein sites. Thrombosis or other blockages are removed by placinganother catheter into the entry-port. And the medical professional isable to carry out the changing of the catheter without the need for asterile field. Once a multi-use entry-port is in position, insertingreplacement catheters or adjusting the position of the catheter ispossible, even in the most extreme circumstances.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and its features andadvantages will become apparent to those skilled in the art by referenceto the ensuing description, taken in conjunction with the accompanyingdrawings, in which:

FIG. 1 is a schematic partial cross-sectional view illustratinginsertion of a multi-use entry-port forming part of an intravenouscatheter system into a vein of a subject, in accordance with a preferredembodiment of the present invention;

FIG. 2 is a schematic partial cross-sectional view illustratingwithdrawal of the needle from the inserted multi-use entry-port of thecatheter system of the present invention;

FIG. 3 is a schematic partial cross-sectional view illustrating aflexible catheter prior to connecting to the multi-use entry-port andinsertion therein;

FIG. 3A, is a schematic isometric projection view of a flexible catheterincluding an integral sterile environment containment element prior toconnecting to the multi-use entry-port;

FIG. 4 is a schematic partial cross-sectional view illustrating theflexible catheter connected to the multi-use entry-port prior toinsertion through the multi-use entry-port prior to insertion into thevein of a subject;

FIG. 5 is a schematic partial cross-sectional view illustrating theflexible catheter inserted through the multi-use entry-port into thevein of a subject;

FIG. 6 is a schematic view showing alternative shapes of a second freeend of a multi-use entry-port;

FIG. 7 is a schematic partial cross-sectional view of a second end of amulti-use entry-port with a catheter tube extending therethrough;

FIG. 8 is a schematic partial cross-sectional view illustrating use of astiffening element within the flexible catheter;

FIG. 9 is a schematic partial cross-sectional view illustrating theflexible catheter, having a stiffening element, connected to themulti-use entry-port prior to insertion through the multi-use entry-portprior to insertion into the vein of a subject;

FIG. 10 is a schematic partial cross-sectional view illustrating thestiffening element within the flexible catheter, fully inserted throughthe multi-use entry-port into the vein of a subject;

FIG. 11 is a schematic partial cross-sectional view illustrating aflexible catheter tube inserted through the multi-use entry-port intothe vein of a subject, the stiffening element withdrawn from theflexible catheter;

FIG. 12 is a schematic view of a multi-use entry-port having a lockingdevice;

FIG. 13 is a schematic view of a multi-use entry-port having a flowcontrol valve; and

FIG. 14 is a schematic view of a cylindrical receptacle for containing acoiled catheter tube in a sterile environment.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to an apparatus and a method wherebyintravenous therapy is applied to a subject, such that the incidence ofphlebitis or thrombosis in a vein of the subject is substantiallyreduced without necessitating a multiplicity of intravenous entries.This is generally achieved by the use of a short multi-use entry-port ora standard intracatheter disposed in a vein of the subject. Thereafter,a catheter having a flexible tube or cannula of a predetermined length,is attached thereto and slidably inserted therethrough into the vein ofthe subject. This procedure is sequentially illustrated in FIGS. 1 to 5and described hereunder, in accordance with a preferred embodiment ofthe present invention. To reduce the risk of phlebitis or thrombosis,the catheter is periodically replaced with another of a differentlength, or the position of the catheter adjusted, without necessitatingremoval and relocation of the entry-port.

Referring to FIG. 1 there is seen a partial cross-sectional view of askin surface referenced 20 and a subcutaneous vein-wall referenced 22.Also seen is a multi-use entry-port, generally referenced 10,subcutaneously introduced into vein 22. Entry-port 10 includes a cannulareferenced 24, securing lugs referenced 30, a hub referenced 31, and aLuer Lock adapter referenced 32 attached thereto. To facilitate piercingof the skin 20 and vein-wall 22 and achieving entry thereto, by cannula24, a needle generally referenced 26 is slidably positioned withinmulti-use entry-port 10. A sharp extremity referenced 28 of needle 26protrudes from a second end referenced 34 of cannula 24 and, to retainneedle 26 in this position, it is fastened to adapter 32 by a threadedneedle hub referenced 27.

It is necessary to avoid transfixing the vein 22. After needle extremity28 has pierced skin 20 and vein-wall 22, and cannula end referenced 34has entered a short distance into vein-wall 22, needle 26 is partiallywithdrawn holding hub 27, such that extremity 28 is no longer exposed.Referring now to FIG. 2, there is seen multi-use entry-port 10, insertedthrough skin 20 and vein wall 22, having needle 26 slidably withdrawntherefrom.

Thereafter, referring to FIG. 3, there is seen, in accordance with apreferred embodiment of the present invention, adjacent to entry port 10and prior to connection thereto, a flexible catheter, generallyreferenced 40, having a flexible tube referenced 42 contained in anintegral sterile sheath, referenced 48. Catheter 40 has a Luer Lockconnector referenced 46 at a first end thereof. To facilitate dispensingof an additional medication, a second port referenced 49, having aremovable cover cap referenced 51, is preferably formed at the first endof catheter 40. Referring now to FIG. 3A, there is seen an isometricprojection view of catheter 40, having an integral sterile environmentcontainment sheath, prior to connecting to the multi-use entry-port andentry-port 10, including a cover cap referenced 52 fastened overconnector 46. A Luer Lock slide adapter-connector referenced 44 is seenat a second end of catheter 40 thereby to connect second end of catheter40 to adapter 32 of entry-port 10.

In order to facilitate insertion of catheter tube 42 through entry port10 and into vein 22, and, referring now to FIG. 4, there is seencatheter 40 having Luer Lock slide adapter-connector 44 connected toLuer Lock adapter 32 of multi-use entry-port 10. Tube 42 is thenslidably inserted through multi-use entry-port 10 into vein 22 of thesubject.

Furthermore, referring to FIG. 5, there is seen flexible tube 42 inposition in vein 22, after being slidably pushed through slideadapter-connector 44 into multi-use entry-port 10 and thereafter intoand along vein 22. Luer Lock connector 46 is moved until it is adjacentto Luer Lock slide adapter-connector 44 and fixably attached thereto.Sterile sheath 48 is seen in a collapsed configuration, referenced 50.After removing cover cap 52, there is seen exposed a connectorreferenced 56, thereby to facilitate connecting thereto an intravenoustherapy device (not shown) such as an intravenous drip or hypodermicsyringe.

Referring now to FIG. 6, there is seen, in accordance with a furtherembodiment of the present invention, a schematic isometric view ofentry-port 10 together with alternative configurations of end 34thereof. View A illustrates a straight cylindrical edge, generallyreferenced 53. View B illustrates a tapered end generally referenced 55having a tapered edge referenced 57 and an internal compression lip sealreferenced 59. Referring now to FIG. 7, there is seen a partialcross-sectional view of end 34 of cannula 24 with catheter tube 42passing therethrough. To achieve a seal between multi-use entry-port 10and catheter flexible tube 42, as mentioned above, second end 34 ofmulti-use entry-port 10 has a taper 57, thereby to form an internalcompression lip seal 59 against flexible tube 42.

In accordance with an alternative embodiment of the present invention,for specific applications, it is necessary to provide a stiffeningeffect to tube 42 for insertion into vein 22. Introduction of astiffened catheter tube 42 is sequentially illustrated in FIGS. 8 to 11.Referring now to FIG. 8, there is seen a catheter, generally referenced60, substantially similar to that seen in FIGS. 1-7 hereinabove,including a stiffening element referenced 62 disposed slidably withinflexible tube 42. A cover cap referenced 64 at a first end thereof,serves as a hub to stiffening element 62. Stiffening element 62facilitates insertion of catheter flexible tube 42 into a subject'svein. Referring to FIG. 9 there is seen catheter 60 connected usingconnector 44 to entry-port 10 at adaptor 32. There is further seen inFIG. 10, flexible tube 42, including stiffening element 62 therein,fully inserted into a subject's vein 22 and, there is seen in FIG. 11,stiffener 62 slidably withdrawn from tube 42 utilizing cover cap hub 64.

In accordance with a further embodiment of the present invention,referring to FIG. 12, multi-use entry-port 10 is formed having a lockingdevice referenced 66 thereby to fasten catheter tube 42 at apredetermined position, relative to multi-use entry-port 10 and to thesubject's vein 22. Sheath 48 (FIG. 3) is seen in a partially collapsedconfiguration, referenced 69, thereby to maintain sterility of theuninserted portion of tube 42, that is, the portion remaining externalto entry port 10. In accordance with another embodiment, referring nowto FIG. 13, multi-use entry-port 10 has a valve referenced 68 formedthereto, thereby to control or stop the rate of flow of liquid throughcatheter tube 42.

With regard to maintaining catheter tube 42 in a sterile environmentprior to and during use, in accordance with a variation in an embodimentof the present invention, there is an integral sterile environmentcontainer, alternative to sterile sheath 48 (FIG. 3). Referring now toFIG. 14, there is seen a generally cylindrical sterile container,generally referenced 70, including a casing referenced 72, an inlet portreferenced 74, having a connector 75, axially disposed with respect tocasing 72. There is seen a tangentially disposed outlet port referenced77 having a Luer Lock and a connector referenced 78 thereby to connectport 77 to connector 32 of entry-port 10. Catheter tube 42 is coiledreference 76 within casing 72. After connector 77 is attached toentry-port 10 at adapter 32, catheter tube 42 is extended by reelingfrom container 70 utilizing a knurled handle referenced 79, thereby topass through entry-port 10 into a vein (not shown) of a subject.

An added variation of this embodiment to the present invention includesa clutch device incorporated into container 70, thereby controlling theforce exerted on extending catheter tube 42 using knurled handle 79.This reduces the risk of damaging or piercing vein 22 while insertingcatheter tube 4 through entry port 10 into vein 22.

Sterile container 70 has advantages of being compact and easily handledby a medical professional even in non-ideal circumstances.

There are practical advantages to the above-mentioned apparatus andmethod of insertion of a flexible catheter tube into a subcutaneous veinof a subject. The initial stage for carrying out the method inaccordance with the preferred embodiment of the present invention issubstantially similar to that presently utilized in most hospitals,using a short catheter or intracatheter. A multi-use entry-port orintracatheter is inserted into a subcutaneous vein of the subject. Thisrequires no stitching to a subject's limb to be fixed in position.Adhesive tape is a successful securing device. The preferred embodimentfurther teaches the insertion of the flexible catheter tube into andthrough the entry-port or intracatheter and into the vein and secured tothe entry port.

Furthermore, should there be an occurrence of fever or thrombosis, theflexible catheter tube is removed from the intracatheter and a newcatheter tube inserted in its stead. Both medical professional andsubject are spared the trauma and time of re-inserting the intracatheterinto another site. The removed catheter tube tip is sent for laboratoryculture testing. In addition, should the subject experience any pain atthe site of the tube tip due to phlebitis, another shorter or longercatheter tube is used to replace the troublesome tube withoutnecessitating the re-insertion of the entry-port.

With regard to maintaining sterility of the equipment and the subject,the above-mentioned procedure has an advantage insofar as there is norequirement for a sterile field of application of the catheter tube.Because the flexible tube is supplied in an integral sterile container,insertion may be carried out under virtually any conditions, in the openand unaffected by environmental contamination. Furthermore, only onemedical professional, with little additional training, is able to carryout this procedure, without any specific immobilization or trauma of thesubject. The procedure offers a safe and convenient method foratraumatic administration of intravenous therapy.

The present invention, also, provides for insertion of catheters andother similar tubular devices through a multi-use entry port intovarious organs of the body. The entry port provides the medicalprofessional with the means for repeatedly accessing an organ withouthaving to repeatedly pierce the skin and organ wall of the subject. Inaddition, such access is achieved without requiring a sterileenvironment since each tubular device to be inserted is enclosed withinan integral sterile container.

It will be appreciated by persons skilled in the art that the presentinvention is not limited by the drawings and description hereinabovepresented. Rather, the invention is defined solely by the claims thatfollow.

1. An improved intravenous catheter system including a) a multi-useentry-port element having first and second ends having a bore formedthere-between, said port element configured for transcutaneouspositioning such that said second end is brought into liquid flowcommunication with a vein of a subject; and b) a catheter having firstand second ends and a flexible catheter-tube there-between, saidcatheter tube having a predetermined length and a diameter adapted forslidable insertion through said entry-port element into the vein of thesubject.
 2. An improved intravenous catheter system according to claim 1wherein said multi-use entry-port element includes a) a hub having aslide adapter-connector fixably disposed at said first end of saidentry-port element, thereby to provide sealed slidable access of saidcatheter-tube into said entry-port element and thereafter into the veinof the subject; b) a cannula having an aperture formed at a second endthereof, said cannula fixably attached to said hub and disposed at saidsecond end of said entry-port element, said cannula adapted forinsertion into the vein of the subject; and c) a removable needle havingfirst and second ends having a needle-hub attached at said first end,having a sharp extremity at said second end and having a lengthsufficient to extend through said entry-port element, said needleslidably housed in said entry-port, said sharp extremity projectingbeyond said aperture at said second end of said cannula thereby topierce through the skin and vein wall into the vein of the subject, andthereby to provide entry into the vein for said cannula.
 3. An improvedintravenous catheter system according to claim 2 wherein said entry-portelement includes mounting lugs fixably disposed thereto, thereby tosecure said entry-port element to the subject.
 4. An improvedintravenous catheter system according to claim 2 wherein said second endof said cannula is formed with a taper, thereby to provide a compressionlip seal between said cannula aperture and said catheter tube.
 5. Animproved intravenous catheter system according to claim 2 wherein saidslide adapter-connector includes a Luer Lock.
 6. An improved intravenouscatheter system according to claim 1 wherein said catheter includes a) aconnector element disposed at said first end of said catheter and havinga removable cap, said connector element configured to facilitate, in theabsence of said cap, connection of an intravenous therapeutic device tosaid first end of said catheter; b) a slidable-connector elementdisposed at said second end of said catheter and having a removable cap,said slidable-connector element, configured to facilitate connection ofsaid second end of said catheter to said first end of said entry-portelement, thereby to facilitate sliding said catheter tube therethroughinto said entry-port element and thereafter into the vein of thesubject.
 7. An improved intravenous catheter system according to claim 6wherein said connector element includes a Luer Lock.
 8. An improvedintravenous catheter system according to claim 1, and also including anintegral sterile environment containment element for enclosing saidcatheter tube within a sterile environment.
 9. An improved intravenouscatheter system according to claim 8 wherein said integral sterileenvironment containment element is selected from the group whichconsists of: a) a longitudinal collapsible sheath configured to containsaid catheter tube longitudinally therewithin; and b) a cylindricalcasing configured to contain said catheter tube as a withdrawable coiltherewithin.
 10. An improved intravenous catheter system according toclaim 9 wherein said cylindrical casing includes a clutch device therebyto control forceful insertion of said catheter tube through said entryport into a vein, so as to avoid damaging the vein wall.
 11. An improvedintravenous catheter system according to claim 1, and also including aremovable stiffener element slidably disposed within said flexiblecatheter tube, thereby to increase the stiffness of said catheter tube,and thereby to aid insertion thereof through said entry-port elementinto the vein of the subject.
 12. An improved intravenous cathetersystem according to claim 1 wherein said entry-port element includes aselectably operable locking device for locking said catheter tube in aselected position with respect to a selected drug delivery locationwithin the vein of the subject.
 13. An improved intravenous cathetersystem according to claim 1 wherein said entry-port element includes avalve for regulating a flow of liquid through said catheter tube. 14.For use with an intravenous cannula element having first and second endsand having a bore formed therebetween, said cannula element configuredfor transcutaneous positioning such that said first end is adapted toprotrude from a limb of a subject and said second end is brought intocommunication with an interior of a body organ of a subject, aself-contained sterile catheter apparatus which includes a) first andsecond ends and a flexible catheter tube therebetween, said cathetertube having a predetermined length and a diameter adapted for slidableinsertion through said bore of said intravenous cannula element into thebody organ of the subject, and b) an integral sterile environmentcontainment element thereby to allow insertion of said catheter tubethrough said cannula element into the body organ of a subject in agenerally non-sterile environment.
 15. For use with an intravenouscannula element according to claim 14 wherein said catheter includes a)a connector element disposed at said first end of said catheter andhaving a removable cap, said connector element configured to facilitate,in the absence of said cap, connection of an intravenous therapeuticdevice to said first end of said catheter; b) a slidable-connectorelement disposed at said second end of said catheter and having aremovable cap, said slidable-connector element, configured to facilitateconnection of said second end of said catheter to said first end of saidentry-port element, thereby to facilitate sliding said catheter tubetherethrough into said entry-port element and thereafter into the veinof the subject.
 16. For use with an intravenous cannula elementaccording to claim 14 wherein said integral sterile environmentcontainment element is selected from the group which consists of: a) alongitudinal collapsible sheath configured to contain said catheter tubelongitudinally therewithin; and b) a cylindrical casing configured tocontain said catheter tube as a withdrawable coil therewithin.
 17. Foruse with an intravenous cannula element according to claim 14 and alsoincluding a removable stiffener element slidably disposed within saidflexible catheter tube, thereby to increase the stiffness of saidcatheter tube, and thereby to aid insertion thereof through saidentry-port element into the vein of the subject.
 18. A method forintroducing an improved intravenous catheter system into a subcutaneousvein of a subject, said method including the steps of: a) introducing amulti-use entry-port, having a removable piercing-needle slidably housedtherein, into an outer wall of a subcutaneous vein of a subject; b)withdrawing the removable piercing-needle from the entry-port; c)advancing the multi-use entry-port into the vein; d) connecting acatheter device, having a flexible catheter tube, to the entry-port; ande) slidably inserting the flexible catheter-tube through the entry-portinto the subcutaneous vein of the subject.
 19. The method according toclaim 18 wherein said step of introducing includes the step of securingthe entry-port element to the skin of the subject.
 20. The methodaccording to claim 18 wherein withdrawing the removable piercing-needlefrom the entry-port includes the step of partially withdrawing theremovable piercing-needle from the entry-port, to guard the piercingneedle and to avoid transfixing the vein.
 21. A method according toclaim 18, wherein, using a catheter tube having a removable stiffenerelement slidably disposed therein, includes an additional step ofslidably removing the stiffener element from the catheter.